BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2245734 · Received September 2, 2011

    Report

    Report Number
    2953200-2011-01518
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF EVALUATION: (RUPTURED VESSEL/ANEURYSM, CONVERSION TO OPEN REPAIR) (NARROWED AORTIC BIFURCATION WITH CALCIFICATION). CONCLUSION: (NARROWED AORTIC BIFURCATION WITH CALCIFICATION).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 2 MONTHS AGO. THE DISTAL AORTA WAS NARROW AND CALCIFIED, AND THE VESSELS HAD MODERATE TORTUOSITY AND MILD CALCIFICATION. IT WAS REPORTED THAT THE PT PRESENTED EMERGENTLY APPROXIMATELY 1 MONTH POST-IMPLANTATION, AND THE CT DEMONSTRATED A FABRIC-RELATED TEAR (TYPE III ENDOLEAK) AT THE LEVEL OF THE FLOW DIVIDER AND THAT THE ANEURYSM HAD RUPTURED (MFR REPORT #2952200-2011-01517, MFR REPORT #2952200-2011-01518). THE PHYSICIAN BELIEVES THAT THE CAUSE OF THE TYPE III ENDOLEAK IS MOST LIKELY RELATED TO THE NARROW AND CALCIFIED AORTIC BIFURCATION, WHICH MADE IT DIFFICULT TO REMOVE THE TIP OF THE DEVICE. THE PHYSICIAN ELECTED TO CONVERT THE PT TO A PARTIAL OPEN REPAIR AND ONLY REMOVED THE ILIAC LIMB (MFR REPORT #2952200-2011-01519) BEFORE SEWING IN A DACRON GRAFT TO THE BIFURCATED STENT GRAFT; THE TYPE III ENDOLEAK WAS SUCCESSFULLY RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00831898

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention